Viewing data from:

ANAFRANIL

NDA

CLOMIPRAMINE HYDROCHLORIDE | N019906 | SPECGX LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From e5 Pharma, LLC FDA-2014-P-1975 · 5 docket documents e5 Pharma, LLC submitted a suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Animal Drug Application (ANADA) for Clomipramine Hydrochloride Chewable Tablets for dogs, a generic version of Clomicalm® Tablets (NADA	Other	2014-11-19	Granted	e5 Pharma, LLC
PetMedicus Laboratories, Inc. - Citizen Petition FDA-2009-P-0162 · 4 docket documents PetMedicus Laboratories, Inc. filed a suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an abbreviated new animal drug application (ANADA) for generic clomipramine hydrochloride tablets for dogs in 10 mg and 80 mg strengths that di	Other	2009-03-31	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

15 trials from ClinicalTrials.gov, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients NCT00564564	Phase 4	Completed	University of Sao Paulo	21	2006-01 → 2007-12
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions NCT00913952	Phase 1	Completed	Sandoz	18	1994-04 → 1994-06
Citalopram vs Clomipramine vs Placebo in Recurrent Depression NCT01575158	N/A	Completed	University of Aarhus	59	1997-10 → 2007-09
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder NCT00254735	Phase 3	Completed	AstraZeneca	44	2002-04 → 2006-03
Treatment of Obsessive Compulsive Disorder in Children NCT00074815	Phase 3	Completed	Duke University	124	2003-09 → 2009-11
Trial of PED-1 in Male Patients With Premature Ejaculation NCT01439984	Phase 3	Completed	Symyoo	159	2011-09 → 2012-06
Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation NCT01203202	Phase 2	Completed	Symyoo	104	2010-09 → 2011-01
Predicting Medication Response in Obsessive Compulsive Disorder NCT01404871	N/A	Completed	Sunnybrook Health Sciences Centre	26	2009-04 → 2011-12
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions NCT00913783	Phase 1	Completed	Sandoz	36	1992-11 → 1992-12
Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males NCT02028598	Phase 1	Completed	CTC Bio, Inc.	30	2014-01 → 2014-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$0.3113

per ea

Lowest NADAC/Unit

$0.1824

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00406880801CLOMIPRAMINE 75 MG CAPSULE	$0.3113	EA	Generic	—	2026-06-17
00406880701CLOMIPRAMINE 50 MG CAPSULE	$0.2257	EA	Generic	—	2026-06-17
00406880601CLOMIPRAMINE 25 MG CAPSULE	$0.1824	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (6 FSS)

Lowest Price

$1.44

Highest Price

$792.19

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00406-8807-01CLOMIPRAMINE 50MG CAP	$15.42	FSS	SpecGx LLC	09/14/2027
00406-8808-01CLOMIPRAMINE 75MG CAP	$40.68	FSS	SpecGx LLC	09/14/2027
00406-9906-03ANAFRANIL 25MG CAP	$761.01	FSS	SpecGx LLC	09/14/2027
00406-9907-03ANAFRANIL 50MG CAP	$779.91	FSS	SpecGx LLC	09/14/2027
00406-9908-03ANAFRANIL 75MG CAP	$792.19	FSS	SpecGx LLC	09/14/2027
00406-8806-01CLOMIPRAMINE 25MG CAP	$1.44	FSS	SpecGx LLC	09/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Anafranil (2024)

Total Spending

$1.0M

Total Claims

224

Beneficiaries

Avg Cost/Unit

$35.01

Spending Trend

$1.5M(2019)→$1.4M(2020)→$1.3M(2021)→$1.4M(2022)→$1.1M(2023)→$1.0M(2024)

YoY Change:-6.6%

5yr CAGR:-0.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain7 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

LUNDBECK PHARMACEUTICALS ITALY SPACLOMIPRAMINE HYDROCHLORIDE

DMF 88641990

SIGMA ALDRICH IRELAND LTDCLOMIPRAMINE HYDROCHLORIDE

DMF 109491994

TARO PHARMACEUTICAL INDUSTRIES LTDCLOMIPRAMINE HYDROCHLORIDE USP

DMF 130211998

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCLOMIPRAMINE HYDROCHLORIDE

DMF 308142016

RL FINE CHEM PVT LTDCLOMIPRAMINE HYDROCHLORIDE

DMF 319422017

SUN PHARMACEUTICAL INDUSTRIES LTDCLOMIPRAMINE HYDROCHLORIDE USP

DMF 329962018

MANKIND PHARMA LTDCLOMIPRAMINE HYDROCHLORIDE USP

DMF 349352020

IROPHARM LTDInactiveCLOMIPRAMINE HYDROCHLORIDE

DMF 80471989

EVONIK TECHNOCHEMIE GMBHInactiveCLOMIPRAMINE HYDROCHLORIDE

DMF 131271998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
May 14, 2019	SUPPL -43	View Letter (PDF)
Aug 27, 2018	SUPPL -41	View Letter (PDF)
May 25, 2017	SUPPL -40	View Letter (PDF)
Jul 29, 2014	SUPPL -39	View Letter (PDF)
Jul 11, 2014	SUPPL -38	View Letter (PDF)
Oct 29, 2012	SUPPL -37	View Letter (PDF)
Jul 24, 2007	SUPPL -34	View Letter (PDF)
Jan 13, 2005	SUPPL -32	View Letter (PDF)
Sep 7, 2004	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 29, 1989

No patent or exclusivity listings for this strength.

#002 — 50MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 29, 1989

#003 — 75MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Dec 29, 1989